U.S. patent application number 14/751621 was filed with the patent office on 2015-12-31 for conductive coding of syringe information.
The applicant listed for this patent is BAYER MEDICAL CARE INC.. Invention is credited to RICHARD C. MORTON.
Application Number | 20150374907 14/751621 |
Document ID | / |
Family ID | 54929386 |
Filed Date | 2015-12-31 |
United States Patent
Application |
20150374907 |
Kind Code |
A1 |
MORTON; RICHARD C. |
December 31, 2015 |
CONDUCTIVE CODING OF SYRINGE INFORMATION
Abstract
A system for identifying information regarding a syringe
assembly used with a fluid injector includes at least one syringe
assembly having a barrel extending from a distal end to an open
proximal end, at least one indicator provided on at least a portion
of an outer circumferential surface of the barrel, an injector
having at least one syringe port adapted to receive the at least
one syringe assembly, and at least one sensor provided on or within
at least a portion of each syringe port. The at least one indicator
may conduct electricity corresponding to information regarding the
at least one syringe assembly, which is identified by the at least
one sensor.
Inventors: |
MORTON; RICHARD C.; (ALLISON
PARK, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BAYER MEDICAL CARE INC. |
INDIANOLA |
PA |
US |
|
|
Family ID: |
54929386 |
Appl. No.: |
14/751621 |
Filed: |
June 26, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62018205 |
Jun 27, 2014 |
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Current U.S.
Class: |
604/111 |
Current CPC
Class: |
A61M 2205/6018 20130101;
A61M 2205/60 20130101; A61M 5/14546 20130101; A61M 2205/6027
20130101; A61M 5/007 20130101; A61M 2205/6063 20130101 |
International
Class: |
A61M 5/145 20060101
A61M005/145; A61M 5/20 20060101 A61M005/20; A61M 5/50 20060101
A61M005/50 |
Claims
1. A system for identifying information regarding a syringe
assembly used with a fluid injector, the system comprising: at
least one syringe assembly having a barrel extending from a distal
end to an open proximal end; at least one indicator provided on at
least a portion of an outer circumferential surface of the barrel;
an injector having at least one syringe port adapted to receive the
at least one syringe assembly; and at least one sensor provided on
or within at least a portion of each syringe port, wherein the at
least one indicator conducts electricity corresponding to
information regarding the at least one syringe assembly, which is
identified by the at least one sensor.
2. The system as claimed in claim 1, wherein the at least one
indicator comprises at least one conductive ink.
3. The system as claimed in claim 1, wherein the information
regarding the at least one syringe assembly includes at least one
of a syringe assembly type, physical dimensions of the at least one
syringe assembly, flow characteristics of fluid stored in the at
least one syringe assembly, a type of fluid stored in the at least
one syringe assembly, manufacturer of the at least one syringe
assembly, lot number, date of manufacture of the at least one
syringe assembly, expiration of use date of the at least one
syringe assembly, and combinations thereof.
4. The system as claimed in claim 1, wherein the at least one
sensor comprises a conductive elastomeric pad that contacts the at
least one indicator and a flex printed circuit board that
interprets the information regarding the at least one syringe
assembly.
5. The system as claimed in claim 4, wherein, upon contacting the
conductive elastomeric pad, the at least one indicator conducts
electricity from at least one first electrical contact to at least
one second electrical contact that corresponds to the information
regarding the at least one syringe assembly and that is interpreted
by the flex printed circuit board.
6. The system as claimed in claim 1, further comprising a computer
accessory in communication with the at least one sensor.
7. The system as claimed in claim 1, wherein the at least one
indicator extends around an entire outer circumferential surface of
the barrel.
8. The system as claimed in claim 1, wherein the at least one
indicator is formed as at least one strip, at least one geometric
pattern, or combination thereof.
9. The system as claimed in claim 1, wherein the at least one
indicator is formed on the proximal end of the syringe barrel.
10. The system as claimed in claim 1, wherein the at least one
sensor extends around at least a portion of an entire
circumferential surface of the at least one syringe port.
11. The system as claimed in claim 1, wherein the at least one
sensor comprises at least two sensors, and wherein the at least two
sensors are spaced apart from one another along at least one of a
longitudinal axis and a lateral axis of the at least one syringe
port.
12. The system as claimed in claim 1, wherein the at least one
indicator is detectable by the at least one sensor when the at
least one syringe assembly is engaged within the at least one
syringe port.
13. The system as claimed in claim 1, wherein the at least one
indicator comprises a plurality of indicators, and wherein each
indicator corresponds to different information regarding the at
least one syringe assembly.
14. A syringe assembly, comprising: a barrel extending from a
distal end to an open proximal end, and at least one indicator
comprising at least one conductive ink provided on at least a
portion of an outer circumferential surface of the barrel.
15. The syringe assembly as claimed in claim 14, wherein the at
least one indicator corresponds to identifying information about
the syringe assembly, and wherein the identifying information
includes at least one of a syringe assembly type, physical
dimensions of the syringe assembly, flow characteristics of fluid
stored in the syringe assembly, a type of fluid stored in the
syringe assembly, manufacturer of the at least one syringe
assembly, lot number, date of manufacture of the at least one
syringe assembly, expiration of use date of the at least one
syringe assembly, and combinations thereof.
16. The syringe assembly as claimed in claim 14, wherein the at
least one indicator extends around the entire outer circumferential
surface of the barrel.
17. The syringe assembly as claimed in claim 14, wherein the at
least one indicator is formed as at least one strip, at least one
geometric pattern, or combination thereof.
18. The syringe assembly as claimed in claim 14, wherein the at
least one indicator is provided on the proximal end of the
barrel.
19. The syringe assembly as claimed in claim 14, wherein the at
least one indicator comprises a plurality of indicators, and
wherein each indicator corresponds to different information
regarding the syringe assembly.
20. A method for reading identifying information regarding a
syringe assembly provided within a fluid injector, the method
comprising: providing a syringe assembly having at least one
indicator comprising at least one conductive ink provided on at
least a portion of a barrel of the syringe assembly; inserting the
syringe assembly into a syringe port of a fluid injector;
contacting the at least one indicator against at least one sensor,
thereby causing the at least one indicator to conduct electricity
from at least one first electrical contact to at least one second
electrical contact; and receiving identifying information regarding
the syringe assembly based on the electricity conducted by the at
least one indicator.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 62/018,205, filed Jun. 27, 2014, the
disclosure of which is incorporated in its entirety by
reference.
BACKGROUND
[0002] 1. Field of the Technology
[0003] The present disclosure relates generally to a system
including at least one syringe for use with a powered fluid
injector and, more specifically, to a syringe assembly including
conductive coding for identifying information regarding the at
least one syringe assembly.
[0004] 2. Description of Related Art
[0005] In many medical procedures, such as drug delivery, it is
desirable to inject various medical fluids, for example, gene
therapy, cell and biological agent delivery, and delivery of
therapeutic agents generally, into a patient. Likewise, numerous
types of contrast media (often referred to simply as contrast) are
injected into a patient for many diagnostic and therapeutic imaging
procedures. For example, contrast media are used in diagnostic
imaging procedures such as X-ray procedures (including, for
example, angiography, venography, and urography), computed
tomography (CT) scanning, magnetic resonance imaging (MRI), and
ultrasonic imaging. Contrast media are also used during therapeutic
imaging procedures, including, for example, angioplasty and other
interventional radiological procedures.
[0006] In recent years, a number of injector-actuated syringes and
powered injectors for pressurized injection of fluids, such as
contrast media, have been developed. By way of example, in a
typical angiographic procedure, the medical practitioner places a
cardiac catheter into a vein or artery. The catheter is connected
to either a manual or an automatic contrast injection mechanism.
Alternatively, in CT and MRI imaging procedures, contrast may be
injected into a patient's vasculature, for example through a needle
or peripheral cannula. Such imaging agents may be accompanied by or
followed by injection of a medical flushing fluid, such as saline.
The automatic contrast injection mechanism typically includes at
least one syringe assembly connected to a powered injector having,
for example, at least one powered linear actuator. Typically, an
operator enters settings into an electronic control system of the
powered injector for a fixed volume of contrast and/or saline and a
fixed rate of injection. In many systems, there is no interactive
control between the operator and the powered injector, except to
start or stop the injection. In these cases, the injector utilizes
a programmed injection protocol to complete the procedure. A change
in flow rate in such systems occurs by stopping the machine and
resetting the injection parameters. Automation of angiographic
procedures using powered injectors is discussed, for example, in
U.S. Pat. Nos. 5,460,609, 5,573,515, and 5,800,397, incorporated
herein by reference.
[0007] Generally, liquids being injected into a patient, such as
X-ray and magnetic resonance contrast, are clear pharmaceuticals
delivered to a patient during or just prior to a medical imaging
procedure. The liquids may be provided in syringes of different
sizes to accommodate different volumes of fluid that are required
for different patients. Such contrasts can be detected by
sophisticated imaging systems, but are difficult to detect with the
human eye. Different contrasts have different properties, which
make it difficult for a single or standard detector system to
measure a property of the contrast. On the other hand, it is
desirable that the contrast be clear to enable the user to check
for air bubbles, particulates, or other impurities before injecting
the fluid into the patient. These impurities could be solid
particles or chemicals with an identifiable color. For example, if
certain X-ray contrast media is stored improperly, free iodine can
be released, causing the contrast to have a yellow tint. For the
visualization of air bubbles, particles, or chemicals, the contrast
only needs to be transparent, but may be colored.
[0008] It is often necessary for the medical practitioner to
validate each syringe assembly connected to the automatic fluid
injection mechanism prior to performing the injection. Validation
may include confirming that the syringe assembly is genuine (e.g.
to prevent counterfeiting, use of inferior or miss-fitting syringes
that may result in improper mating between the syringe assembly and
injector or may not have the required tolerances for a particular
injection procedure, possibly resulting in malfunction during the
procedure) and determining various characteristics of the syringe
assembly and fluid contained therein. For example, the medical
practitioner may verify that identifying information, such as the
syringe dimensions (e.g. diameter, length, and fluid volume), and
fluid contents are correct for the procedure being performed. In
addition, the medical practitioner may be required to provide
certain information about the syringe assembly, such as frictional
characteristics between the plunger and syringe barrel, fluid
viscosity, delivery rate, and the like (referred to hereinafter as
"injection parameters") to the fluid injector to control piston
force and acceleration to deliver fluid at a desired and controlled
flow rate. Other important identifying information may include
manufacturer, lot number, expiration date or shelf-life indicator,
etc. Including the various desired identifying information may be
difficult given the amount of available surface area and aesthetic
reasons. For example, if the identifying information covers too
much surface area on the syringe, it may impact the technician's
ability to determine if the syringe has been properly filled.
[0009] In some systems, the fluid injector includes a sensor or
reader located on the fluid injector for automatically reading a
label or tag provided on the syringe when the syringe assembly is
inserted in the injector. The label or tag contains certain
information about the syringe assembly. The fluid injector uses the
information extracted from the label or tag to validate the syringe
assembly and to control the injection. Some existing syringe
identification procedures require specific labels or tags that are
applied to the syringe assembly subsequent to manufacturing the
syringe assembly. In certain cases, the medical practitioner must
rotate the syringe assembly until the sensor or reader on the fluid
injector is properly aligned with the syringe identification
feature, resulting in extended pre-injection manipulation and
possible syringe misidentification. The at least one label or tag
may include a plurality of label or tag. Each label or tag may
correspond to different information regarding the syringe
assembly.
[0010] Therefore, there is a continued need for a syringe assembly,
injector, and/or injection system capable of identifying and
validating the size/volume of the syringe assembly, the source of
the provided syringe assembly, and the medical fluid solution
provided in the syringe assembly prior to injection, wherein ease
of use and/or amount of information contained in the identification
feature is increased. The syringe assemblies, injectors, and
systems set forth in the present disclosure are configured to
address some or all of the above-identified problems.
SUMMARY OF THE DISCLOSURE
[0011] The present disclosure generally relates to syringe
assemblies, injectors, injector assemblies, and assemblies and to
methods of identifying information provided from a syringe assembly
used in conjunction with the injector and/or injector assembly.
[0012] According to one aspect of the disclosure, a system for
reading identifying information regarding a syringe used for
injection with an injector, such as a powered injector, is
provided. The system for identifying information regarding a
syringe assembly used with a fluid injector may include at least
one syringe assembly having a barrel extending from a distal end to
an open proximal end, at least one indicator provided on at least a
portion of an outer circumferential surface of the barrel, an
injector having at least one syringe port adapted to receive the at
least one syringe assembly, and at least one sensor provided on or
within at least a portion of each syringe port. The at least one
indicator may conduct electricity corresponding to information
regarding the at least one syringe assembly, which is identified by
the at least one sensor.
[0013] The at least one indicator may comprise at least one
conductive ink. The information regarding the at least one syringe
assembly may include at least one of a syringe assembly type,
physical dimensions of the at least one syringe assembly, flow
characteristics of fluid stored in the at least one syringe
assembly, a type of fluid stored in the at least one syringe
assembly, manufacturer of the at least one syringe assembly, lot
number, date of manufacture of the at least one syringe assembly,
expiration of use date of the at least one syringe assembly, and
combinations thereof. The at least one sensor may include at least
one conductive elastomeric pad that contacts the at least one
indicator and a flex printed circuit board that interprets the
information regarding the at least one syringe assembly. Upon
contacting the at least one conductive elastomeric pad, the at
least one indicator may conduct electricity from at least one first
electrical contact to at least one second electrical contact that
corresponds to the information regarding the at least one syringe
assembly and that is interpreted by the flex printed circuit board.
A computer accessory or processor may be in communication with the
at least one sensor where the computer may have software
programming to interpret or "decode" the identifying information
associated with the at least one indicator. The at least one
indicator may extend around an entire outer circumferential surface
of the barrel. The at least one indicator may be formed as at least
one strip, at least one geometric pattern, or combination thereof.
The at least one indicator may be formed on the proximal end of the
syringe barrel. The at least one sensor may extend around at least
a portion of an entire circumferential surface of the at least one
syringe port. The at least one sensor may include at least two
sensors. The at least two sensors may be spaced apart from one
another along at least one of a longitudinal axis and a lateral
axis of the at least one syringe port. The at least one indicator
may be detectable by the at least one sensor when the at least one
syringe assembly is engaged within the at least one syringe port.
The at least one indicator may include a plurality of indicators.
Each indicator may correspond to different information regarding
the at least one syringe assembly.
[0014] In another aspect of the disclosure, a syringe assembly is
provided. The syringe assembly may include a barrel extending from
a distal end to an open proximal end, and at least one indicator
comprising at least one conductive ink provided on at least a
portion of an outer circumferential surface of the barrel.
[0015] The at least one indicator may correspond to identifying
information about the syringe assembly. The identifying information
may include at least one of a syringe assembly type, physical
dimensions of the syringe assembly, flow characteristics of fluid
stored in the syringe assembly, a type of fluid stored in the
syringe assembly, manufacturer of the at least one syringe
assembly, lot number, date of manufacture of the at least one
syringe assembly, expiration of use date of the at least one
syringe assembly, and combinations thereof. The at least one
indicator may extend around the entire outer circumferential
surface of the barrel. The at least one indicator may be formed as
at least one strip, at least one geometric pattern, or combination
thereof. The at least one indicator may be provided on the proximal
end of the barrel.
[0016] In another aspect of the disclosure, a method for reading
identifying information regarding a syringe assembly provided
within a fluid injector is provided. The method may include
providing a syringe assembly having at least one indicator
comprising at least one conductive ink provided on at least a
portion of a barrel of the syringe assembly; inserting the syringe
assembly into a syringe port of a fluid injector; contacting the at
least one indicator against at least one sensor, thereby causing
the at least one indicator to conduct electricity from at least one
first electrical contact to at least one second electrical contact;
and receiving identifying information regarding the syringe
assembly based on the electricity conducted by the at least one
indicator.
[0017] Further details and advantages of various aspects described
in detail herein will become clear upon reviewing the following
detailed description of the various aspects in conjunction with the
accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1A is a perspective view of a fluid delivery system
including a powered fluid injector and syringe according to an
aspect of the disclosure;
[0019] FIG. 1B is a cross-sectional view of the powered injector
and syringe of FIG. 1A;
[0020] FIG. 2 is an elevational view of the syringe for use with
the powered injector of FIG. 1A, according to an aspect of the
disclosure;
[0021] FIG. 3 is an end view of the syringe of FIG. 2;
[0022] FIG. 4 is a side view of a syringe port of the injector of
FIG. 1A with the syringe of FIG. 1A inserted therein; and
[0023] FIG. 5 is a schematic view of a fluid delivery system
including a syringe and a powered fluid injector according to an
aspect of the disclosure.
DESCRIPTION OF THE DISCLOSURE
[0024] The illustrations generally show preferred and non-limiting
aspects of the systems and methods of the present disclosure. While
the descriptions present various aspects of the devices, it should
not be interpreted in any way as limiting the disclosure.
Furthermore, modifications, concepts, and applications of the
disclosure's aspects are to be interpreted by those skilled in the
art as being encompassed, but not limited to, the illustrations and
descriptions provided herein.
[0025] The following description is provided to enable those
skilled in the art to make and use the described aspects
contemplated for carrying out the disclosure. Various
modifications, equivalents, variations, and alternatives, however,
will remain readily apparent to those skilled in the art. Any and
all such modifications, variations, equivalents, and alternatives
are intended to fall within the spirit and scope of the present
disclosure.
[0026] Further, for purposes of the description hereinafter, the
terms "end", "upper", "lower", "right", "left", "vertical",
"horizontal", "top", "bottom", "lateral", "longitudinal", and
derivatives thereof shall relate to the disclosure as it is
oriented in the figures. The term "proximal" refers to the
direction towards the injector assembly or device and away from the
patient. The term "distal" refers to the outward direction
extending away from the injector assembly or device and toward the
patient. However, it is to be understood that the disclosure may
assume various alternative variations and step sequences, except
where expressly specified to the contrary. It is also to be
understood that the specific devices and processes illustrated in
the attached drawings, and described in the following
specification, are simply exemplary aspects of the disclosure.
Hence, specific dimensions and other physical characteristics
related to the aspects disclosed herein are not to be considered as
limiting. For the purpose of facilitating understanding of the
disclosure, the accompanying drawings and description illustrate
preferred aspects thereof, from which the disclosure, various
aspects of its structure, construction, and method of operation,
and many advantages may be understood and appreciated.
[0027] Provided herein are syringe assemblies, fluid injectors, and
fluid delivery systems for injection of medical fluid, such as a
medicament, a contrast agent, and/or saline, to a patient. The
syringe assemblies, injectors, and fluid delivery systems are
configured with various features to improve validation and
identification of information regarding the syringe and/or the
syringe contents prior to injection to a patient. With reference to
FIGS. 1A and 1B, a fluid injector 10, such as an automated or
powered fluid injector, is illustrated, which is adapted to
interface with and actuate one or more syringe assemblies 12, which
may be filled with a medical fluid F, such as contrast media,
saline solution, or any desired medical fluid. The powered injector
10 may be used during an angiographic or computed tomography and
like procedures to inject medicament, contrast agents, and/or
conventional flushing agents, such as saline, into the body of a
patient prior to, during, and/or after an imaging procedure. The
powered injector 10 may be at least a dual-syringe injector,
wherein the at least two fluid delivery syringe assemblies 12 are
oriented in a side-by-side or other spatial relationship and are
separately actuated by respective linear actuators or piston
elements associated with the powered injector 10 to move a plunger
26 within the syringe body to aspirate or inject one or more fluids
from the at least one syringe assembly 12. Other powered injectors
may include a single syringe or three or more syringes. A suitable
multi-syringe fluid injector is disclosed in U.S. Patent
Application Publication No. 2012/0123257 to Stokes, Jr. et al.,
incorporated herein by reference.
[0028] The injector 10 may be enclosed within a housing 14 formed
from a suitable structural material, such as plastic and/or metal.
The housing 14 may be in various shapes and sizes depending on the
desired application. For example, the injector 10 may be a
free-standing structure configured to be placed on the floor or may
be a smaller design for placement on a suitable table or support
frame. The injector 10 includes one or more syringe ports 16 for
reversibly interfacing with syringes 12 and connecting the injector
10 to the proximal ends of the at least one syringe assembly 12 and
to connect the plungers 26 to respective piston elements (not
shown). The syringe ports 16 may be located in a top surface of the
housing 14, and the housing 14 may be rotatable to direct the
distal end of the at least one syringe assembly 12 in the vertical,
horizontal, or downward facing direction. As will be described
herein, the syringe assembly 12 includes at least one indicator,
such as at least one indicator strip 34 (shown in FIG. 1B), at
least one geometric pattern, or various combinations thereof,
positioned on at least a portion of the outer circumferential
surface of the syringe assembly 12, such as at least partially
around the outer circumference at a proximal portion of the syringe
assembly 12. The at least one indicator strip 34 may be embedded
with or otherwise associated with identifying characteristics and
other identifying information regarding the syringe assembly 12,
including one or more of the syringe type, physical dimensions,
flow characteristics, fluid contents, fluid source or type,
manufacturer of the syringe, lot number, date of manufacture of the
syringe, expiration of use date (i.e., the maximum shelf-life of
the syringe), and similar syringe information, as described herein.
In one aspect, the at least one indicator may comprise at least one
conductive ink painted or printed onto at least a portion of the
outer circumferential surface or inner circumferential surface of
the syringe assembly 12 or onto at least a portion of an indicator
strip 34 or other geometric patter on the outer circumferential
surface of the syringe assembly 12. It is also contemplated that a
plurality of indicator strips 34 and/or other geometric patterns
may be positioned along one or more of a longitudinal axis and a
latitudinal axis of the syringe assembly 12. In various aspects
including more than one indicator strip 34 or geometric pattern,
each indicator strip 34 or geometric pattern may contain at least a
portion of the total information, as described herein, embedded
within or otherwise associated with the indicator strip 34. In
other aspects, each indicator strip 34 or geometric pattern may
contain specific syringe information as described herein. In
another aspect, each indicator strip 34 or geometric pattern may
include the same syringe assembly 12 information to provide a
redundant source of syringe assembly 12 information.
[0029] The at least one indicator strip 34 or geometric pattern may
be read by at least one sensor 36 (shown in FIG. 1B), positioned on
or recessed in at least a portion of the circumferential surface of
the syringe ports 16 of the injector 10. In various aspects, the at
least one sensor 36 may include, for example, at least one of a
conductive elastomeric pad or strip 38 and a flex printed circuit
board (PCB) 40. The conductive elastomeric pad may comprise one or
a plurality of contact points within specific dimensions, such as
length and/or width, along the circumferential surface of the
syringe ports 16. For example, in one non-limiting aspect, the
conductive elastomeric pad or strip 38 of the at least one sensor
may have at least 15 contact points in a three-quarter inch (2 cm)
width, which can create over 32,000 possible information codes
pertaining to each contact point. In other aspects, the conductive
elastomer pad or strip 38 of the at least one sensor 36 may have
from 1 to 30 contact points within a 0.05 to 1.5 inch width within
the circumferential surface of the syringe port 16. The information
codes associated with the contact points may provide the syringe
identifying information necessary to identify the syringe and/or
syringe contents to the injector and/or operating system. The
interaction between the at least one indicator strip 34 or
geometric pattern and the at least one sensor 36 will be described
in greater detail herein. In another aspect, the sensor 36 may be
at least one metal spring contact sensor having one or more contact
points within a specific width or length along the inner surface of
the syringe ports 16.
[0030] A fluid path set (not shown) may be interfaced with the at
least one syringe assembly 12, for example at a port or nozzle 24
of the distal end 22, supported by the powered injector 10 for
delivering fluid from the syringe assembly 12 to a catheter, needle
or other inserted fluid path (not shown) inserted into a patient at
a vascular access site. For example, a flow of saline solution from
one syringe assembly 12 and contrast from a second syringe assembly
12 may be regulated by a fluid control module (not shown) during an
injection procedure. The fluid control module operates various
valves and flow regulating structures, such as pistons or linear
actuators, to regulate the delivery of the saline solution and
contrast to the patient based on user selected injection
parameters, such as injection flow rate, duration, total injection
volume, and ratio of contrast media to saline, which may be
programmed or otherwise entered into the injector operation system.
A suitable multi-syringe injector is described in U.S. Patent
Application Publication No. 2012/0123257, filed on Jan. 24, 2012,
which is assigned to the assignee of the present application, the
disclosure of which has been incorporated herein by reference
hereinabove in its entirety. Other relevant multi-fluid delivery
systems are found in U.S. Patent Application Publication No.
2004/0064041, filed on May 30, 2002, and in U.S. Patent Application
Publication No. 2005/0113754, filed Nov. 25, 2003, both of which
are assigned to the assignee of the present application, and the
disclosures of which are incorporated herein by reference. The
principles of this disclosure may be applied to fluid injectors
that operate only a single syringe assembly 12 assembly or multiple
syringe assemblies, such as, for example two or three syringe
assemblies.
[0031] Having described the structure and function of the powered
injector 10, the at least one syringe assembly 12, containing a
fluid F, for use with the injector 10, according to one aspect of
the disclosure, will now be discussed in greater detail. With
reference to FIG. 2, according to certain aspects, the syringe
assembly 12 generally has a cylindrical syringe barrel 18 formed
from glass or medical-grade plastic. The barrel 18 may extend from
an open proximal end 20 to a distal end 22 with a nozzle 24
extending therefrom. The open proximal end 20 may be sealed with an
elastomeric plunger 26 within the syringe barrel 18. The plunger 26
may be reversibly slideable within the barrel 18. The plunger 26
may form a liquid tight seal against the inner sidewall of the
barrel 18 as it is advanced or withdrawn therethrough through the
action of a piston actuator associated with powered injector 10.
According to certain aspects, an annular flange 28 may extend from
the outer surface of the syringe barrel 18 at a position near the
proximal end 20 of the barrel 18. When the syringe assembly 12 is
interfaced with the injector 10 as shown in FIG. 1A, the flange,
referred to herein as a drip flange 28, may rest against a distal
end 17 of the syringe port 16 to prevent excess fluid expelled from
the syringe assembly 12 from entering the port 16 and fouling the
interior workings of injector 10. The portion of the barrel 18 near
the proximal end 20, for example between the drip flange 28 and the
proximal end 20 of the syringe assembly 12, referred to hereinafter
as the insertion portion 30, is sized and adapted to be inserted in
the syringe port 16 of the injector 10 (shown in FIG. 1B).
Accordingly, in certain aspects, the insertion portion 30 of the
barrel 18 includes one or more locking structures, such as a
locking flange 32, extending outward from the barrel 18. The
locking flange 32 or other locking structure may be adapted to form
a locking engagement with corresponding protrusions or locking
structures within the syringe port 16 of the injector 10 for
releasably holding the syringe assembly 12 in the syringe port 16
while the injector 10 is in use. Alternatively, the insertion
portion 30 may include various latches, locking mechanisms, or
radially extending ribs for connection to corresponding portions of
the syringe port 16. One aspect of a suitable syringe assembly 12
for use with the injector 10 depicted in FIGS. 1A and 1B may be
found in U.S. Pat. No. 5,383,858, issued Jan. 24, 1995, and which
is assigned to the assignee of the present application, the
disclosure of which is incorporated herein by reference in its
entirety. Other relevant syringe aspects may be found in U.S. Pat.
No. 6,322,535, issued Nov. 27, 2001, and in U.S. Pat. No.
6,652,489, issued Nov. 25, 2003, each of which are assigned to the
assignee of the present application, and the disclosures of which
are both incorporated herein by reference.
[0032] With reference to FIGS. 1B-3, the syringe assembly 12, in
one aspect, includes the at least one indicator strip 34 or
geometric pattern positioned on at least a portion of an outer
circumferential surface of the insertion portion 30. The indicator
strips 34 or geometric patterns are configured to be located and
read by at least one sensor in the injector 10, such as the at
least one sensor 36 depicted in FIG. 1B. In an alternative aspect,
the at least one indicator strip 34 may be embedded in the
insertion portion 30 of the syringe assembly 12 during a molding or
manufacturing process of the syringe assembly 12. In certain
aspects, the at least one indicator strip 34 may have at least one
conductive ink including conductive ink having coding for
converting identifying information regarding the syringe assembly
12 that is inserted into the injector syringe ports 16. The at
least one conductive ink may result in a printed object or
circuitry that conducts electricity, for example over specific
electrical circuits and pathways, corresponding to specific
information regarding the syringe assembly 12. Different conductive
inks, for example, having different electrical conductive and/or
resistance properties may be used for different indicators of a
plurality of indicators. The conductive ink may be printed or
painted onto the insertion portion 30 of the syringe assembly 12 or
on the outer surface of indicator strips 34 and may provide a
conductive pathway for electrical signals that are read and
interpreted by corresponding sensors on the interior surfaces of
the at least one syringe port 16, for example, by conducting
electricity from at least one first electrical contact of the
sensor to at least one second electrical contact of the sensor.
Contact between the sensor and the at least one first electrical
contact of the sensor to at least one second electrical contact
allows specific electrical circuits to form and conduct electricity
through specific pathways corresponding to identifying information
for the at least one syringe assembly 12. It is also contemplated
that nearly transparent conductive inks could be used for covert or
"invisible" coding on the insertion portion 30 of the syringe
assembly 12. Various patterns for positioning the indicator strip
34 on the insertion portion 30 of the syringe assembly 12 are
contemplated, including, equidistantly from one another, in small
groups, variably-spaced from one another, or arranged in patterns
around the circumference of the syringe body. However, the exact
placement of the indicator strips 34 may not be critical as the at
least one sensor 36, such as the conductive elastomeric pad or
strip 38 or flex PCB 40, and the indicator strips 34 could have a
finer resolution of detection. In other aspects, close association
between the indicator strips 34 and the sensor 36 may be necessary
for accurate reading and interpretation of the information on the
conductive indicator strips 34.
[0033] With continued reference to FIGS. 1B-3, the one or more
indicator strips 34 or geometric patterns may be embedded with or
associated with identifying information about the syringe assembly
12 and/or the fluid F contained or to be contained therein. For
example, the information may include the physical dimensions of the
syringe assembly 12 (e.g., length and diameter, fluid volume,
nozzle dimensions, etc.) or other information, such as, but not
limited to, flow characteristics of a fluid stored in the at least
one syringe assembly, a type of fluid stored in the at least one
syringe assembly, manufacturer of the at least one syringe
assembly, lot number, date of manufacture of the at least one
syringe assembly, expiration of use date of the at least one
syringe assembly, and combinations thereof. In addition, the one or
more indicator strips 34 may include identifying information
corresponding to physical parameter information for the syringe
assembly 12, including date of manufacture, lot number and source,
barrel/plunger friction characteristics, fluid pressure limitations
and maximums, maximum or minimum flow rates, and fluid type. The
physical parameter information and other identifying information
about the syringe assembly 12 may be used to determine a preferred
injection force, injection velocity, and appropriate power level
for the linear actuator of the injector 10 and may also be used to
determine if the syringe is appropriate for the indicated usage.
Examples of types of relevant information that may be communicated
or transmitted between a syringe assembly and an injector and/or
operating system is discussed, for example, in U.S. Pat. No.
6,743,202, issued Jun. 1, 2004, and which is assigned to the
assignee of the present application, the disclosure of which is
incorporated herein by reference in its entirety.
[0034] According to certain aspects, the syringe assembly
information may be directly embedded on the indicator strips 34
and/or the circuits formed therefrom when contacted with the sensor
elements, and may be readable by a suitable electronic, optical, or
imaging sensor for reading and extracting information from the
indicator strips 34. Alternatively, relevant information on the
syringe assembly 12 may not be embedded directly with the indicator
strips 34 itself, but the indicator strips 34 may contain
information that serves as a pointer directing the injector, a
computer, processor, or controlling device to a location on a
computer database, computer network, hospital information network,
internet, or similar data storage location, by a wired or wireless
connection, where specific information about the syringe assembly
12 is located and the information regarding information location
may be read via the at least one sensor, such as sensor 36 upon
interaction with the one or more indicator strips 34. Once located,
the stored information can be downloaded to a computer accessory
viewable by the injector operator or directly to the injector or
injector operating system for preparing, adjusting, or modifying
injection parameters.
[0035] The at least one indicator strip 34 may be provided in
various shapes and spatial orientations around the outer
circumferential surface of the insertion portion 30, depending on
the size and/or shape of the insertion portion 30, injector 10,
sensor 36 location, and/or syringe port 16. For example, the
indicator strip 34 may be rectangular in shape or have another
geometric shape or pattern. Alternatively, the indicator strips 34
may include a dotted line, with small or larger portions separated
by spaces provided in between each portion. The dotted line may
optionally surround at least a portion of the outer circumferential
surface of the insertion portion 30. Further, the indicator strips
34 may have any appropriate shape, including a combination of a
variety of shapes for separate portions of the indicator strip or
adjacent or neighboring strips, for example, a circular,
elliptical, or polygonal shape, such as triangular, quadrilateral,
or other multisided shape. In certain cases, the shapes and their
spatial orientation of the various features on the indicator strips
34 may also provide specific information regarding the syringe
assembly parameters and identity when contacted by the sensor.
[0036] As shown in FIGS. 1B and 4, the at least one sensor 36 of
the injector 10 may be positioned on an inner surface of the
syringe port 16. For example, according to certain aspects, at
least one conductive elastomeric pad 38 may be attached to the flex
PCB 40 and positioned on the inner surface of the syringe port 16.
The at least one sensor 36 may extend around the entire
circumferential surface of the syringe port 16 and may read the
various portions and coding of the appropriately aligned indicator
strip 34. Alternatively, the at least one sensor 36 may only extend
around a portion of the circumferential surface of the syringe port
16. In one aspect, a single sensor 36 may be provided in the
syringe port 16 for reading information from the indicator strips
34 of the syringe assembly 12. According to certain aspects, the
single sensor 36 may read information from multiple indicator
strips 34 as the insertion portion 30 is inserted into syringe port
16. In another aspect, at least two sensors 36 are provided in the
syringe port 16 of the injector 10. In one aspect, one sensor 36
may be positioned above another sensor 36 along a longitudinal axis
of the syringe port 16. By providing at least a second conductive
elastomeric pad 38 and flex PCB 40, a redundant reading could be
produced to ensure the correct information is being relayed from
the indicator strips 34. Further, the second sensor 36 may be used
to read a second coded pattern on a second or additional indicator
strip 34 that cannot be read by the first sensor 36 from the first
indicator strip 34. In this aspect, the first sensor 36 may be
configured to read a first coded pattern relating to certain
identifying information, e.g. syringe size, and the second sensor
36 may be configured to read a second coded pattern relating to
different identifying information, e.g. syringe has been pre-filled
with specific medical fluid F. According to other aspects, some but
not all of the at least one indicator strip 34 on the syringe
assembly 12 may contain relevant information regarding the syringe
assembly and the contents and other indicator strips 34 on the
syringe assembly 12 may contain no information and are not read by
the at least one sensor 36.
[0037] Continuing with reference to FIG. 4, having described the
structure of the syringe assembly 12, the at least one indicator
strip 34 and the at least one sensor 36, the interaction between
the syringe assembly 12 and syringe port 16 of the injector 10 will
be further described. In one aspect, the at least one sensor 36 may
be positioned on at least one inner surface of the syringe port 16.
For example, at least one of sensor 36 may be positioned at a
distal end 17 of the syringe port 16. In other aspects, at least
one sensor 36 may be located more proximally within the syringe
port 16. In certain aspects, the flex PCB 40 of the at least one
sensor 36 may be recessed within or below the inner surface of the
syringe port 16. The user may insert the insertion portion 30 of
the syringe assembly 12 into the syringe port 16 of the injector
10, causing the at least one indicator 34 to contact the at least
one sensor 36 when the syringe assembly is in the correct, locked
position. In certain aspects, the user may rotate the syringe
assembly 12 to establish direct contact between the indicator
strips 34 and the sensor 36. In other aspects, the syringe assembly
12 may be inserted in any direction or in a direction determined by
the construction of syringe port 16 and the at least one sensor 36
may be configured to contact and read information from the at least
one indicator strip 34 regardless of the orientation at which the
syringe assembly 12 is inserted. For example, the at least one
sensor 36 may be located continuously or discontinuously around the
complete circumference of syringe port 16 such that the sensor is
configured to read the indicator strip 34 over the entire
circumference of the insertion portion 30 of the syringe assembly
12. In still other embodiments, the syringe may self-orient itself
during the insertion process to place the at least one indicator 34
and the at least one sensor 36 in the correct position to interact.
Once direct electrical contact is established between the at least
one conductive ink of the indicator strip 34 and the at least one
sensor 36, syringe assembly information may be downloaded to or
retrieved from the at least one indicator strip 34 by the at least
one sensor 36. As the syringe assembly 12 is inserted into the at
least one syringe port 16, one of the indicators 34 may contact the
sensor 36 and, in particular, the conductive elastomeric pad 38,
thereby causing the conductive ink of the indicator 34 to conduct
electricity from at least one first electrical contact on the
sensor to at least one second electrical contact on the sensor. The
conducted electricity is directed to the flex PCB 40, which
interprets the conducted electricity to determine specific
information regarding the syringe assembly 12, for example, based
on features of the circuit formed by the electrical contact. The
conductive ink of the indicator 34 may contact one or more contact
points of the elastomeric pad 38, thereby causing the conductive
ink to conduct electricity.
[0038] With reference to FIG. 5, one aspect of an injection system
100 including the at least one syringe assembly 12, the attached at
least one indicator strip 34, injector 10, and the at least one
sensor 36, is illustrated. In use, an operator inserts the proximal
end 20 of the at least one syringe assembly 12 into the at least
one syringe port 16. Other aspects may include two syringe
assemblies and two corresponding syringe ports on the injector 10.
The operator may be required to exert some force against the
syringe assembly 12 so that the locking flange 32 or other locking
mechanism of the syringe assembly 12 engages with the corresponding
locking structures (not shown) of the syringe port 16 until the
insertion portion 30 of the syringe barrel 18 is entirely inserted
into and engaged with syringe port 16. Once the syringe assembly 12
is inserted in the syringe port 16, the operator may optionally
twist and rotate the syringe assembly 12 relative to the syringe
port 16 until the syringe assembly 12 is in the "home" or
"ready-to-use" position or the syringe assembly 12 may self-orient
itself during insertion into syringe port 16. In other aspects, the
injection head and syringe port 16 may include a spring loaded or
other locking mechanism which automatically rotates the syringe
assembly 12 into the "ready-to-use" position, thereby reducing
opportunity for operator error during the insertion process.
Twisting the syringe assembly 12, either manually or automatically,
may bring the at least one indicator strip 34 located on the outer
surface of the barrel 18 into contact with the at least one sensor
36 and, more specifically, the at least one conductive elastomeric
pad 38 of the at least one sensor 36. In still other aspects where
the at least one sensor 36 may read the entire outer
circumferential surface of the syringe assembly 12, the syringe
assembly 12 may not need a specific angle of rotation or
orientation to place the at least one indicator strip 34 and at
least one sensor 36 in the "ready-to-use" position. When the at
least one indicator strip 34 and the at least one sensor 36 are
correctly aligned with respect to one another, the injector 10 may
be configured to read and send the information from the at least
one indicator strip 34 to one or more computer accessory or
processor 110, such as a computer processor, a computer terminal,
injector software, hospital information network, or portable
electronic device, such as a cell phone, computer tablet, or laptop
computer, by a wired or wireless connection, associated with the
injector 10, for example to provide a visual or audible alert
regarding the identifying information about the syringe assembly
12. This information may be used by the injector 10, for example,
to prepare, modify, or adapt the injector settings based on the
identifying information prior to initiating the injection process.
Similarly, the injector 10 may be configured to warn an operator or
cancel or prevent the injection procedure if the loaded syringe
assembly 12 or fluid F contained therein is inappropriate for the
procedure to be performed or if the syringe assembly 12 is not
configured for the specific injector. Assuming that the syringe
assembly 12 and fluid are correct, the injector 10 may
automatically begin the injection procedure, optionally using a
portion of the information contained in the at least one indicator.
Alternatively, the operator may be required to initiate the
injection procedures by an actuation activity, such as pressing a
start button. Once the injection is actuated, the linear actuator
of the injector 10 contacts and engages the proximal end of the
plunger 26 disposed within the syringe barrel 18, for example to
initiate filling of an empty syringe or begin injection for a
prefilled syringe. Once the at least one syringe 12 is filled with
fluid, movement of the plunger 26 in a proximal direction may draw
in fluid into the syringe assembly 12 via negative pressure.
Movement of the plunger 26 in the distal direction expels fluid
contained within the syringe assembly 12 from the nozzle 24,
thereby injecting fluid through a tubing assembly into the patient
through any known injection structure, such as an IV tube or needle
accessory.
[0039] Although the disclosure has been described in detail for the
purpose of illustration based on what is currently considered to be
the most practical and preferred aspects, it is to be understood
that such detail is solely for that purpose and that the disclosure
is not limited to the disclose aspects, but, on the contrary, is
intended to cover modifications and equivalent arrangements. For
example, it is to be understood that the present disclosure
contemplates that, to the extent possible, one or more features of
any aspect can be combined with one or more features of any other
aspect.
* * * * *